NDC 58716-433
OBREDON
Hydrocodone Bitartrate And Guaifenesin
OBREDON is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Sovereign Pharmaceuticals, Llc. The primary component is Hydrocodone Bitartrate; Guaifenesin.
| Product ID | 58716-433_7c47fb93-8438-2a78-e053-2991aa0a0993 |
| NDC | 58716-433 |
| Product Type | Human Prescription Drug |
| Proprietary Name | OBREDON |
| Generic Name | Hydrocodone Bitartrate And Guaifenesin |
| Dosage Form | Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2014-12-30 |
| Marketing Category | NDA / NDA |
| Application Number | NDA205474 |
| Labeler Name | Sovereign Pharmaceuticals, LLC |
| Substance Name | HYDROCODONE BITARTRATE; GUAIFENESIN |
| Active Ingredient Strength | 3 mg/5mL; mg/5mL |
| Pharm Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |
| DEA Schedule | CII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 58716-433-04
118 mL in 1 BOTTLE (58716-433-04)
| Marketing Start Date | 2014-12-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 58716-433-04 [58716043304]
OBREDON SOLUTION
| Marketing Category | NDA |
| Application Number | NDA205474 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-12-30 |
| Inactivation Date | 2020-01-31 |
NDC 58716-433-16 [58716043316]
OBREDON SOLUTION
| Marketing Category | NDA |
| Application Number | NDA205474 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-12-30 |
| Inactivation Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| HYDROCODONE BITARTRATE | 2.5 mg/5mL |
OpenFDA Data
| SPL SET ID: | f73fdec5-d330-4d8c-894b-d0bcf5490624 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Opioid Agonist [EPC]
- Opioid Agonists [MoA]
NDC Crossover Matching brand name "OBREDON" or generic name "Hydrocodone Bitartrate And Guaifenesin"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 58716-433 | OBREDON | Hydrocodone Bitartrate and Guaifenesin |
| 69101-620 | Hydrocodone Bitartrate and Guaifenesin | Hydrocodone Bitartrate and Guaifenesin |
Trademark Results [OBREDON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OBREDON 86461442 4847720 Live/Registered |
Sovereign Pharmaceuticals, LLC 2014-11-21 |
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